NCT03943654: INACT2

Improving Nighttime Access to Care and Treatment (Part 2)

Completed Last updated 20 July 2022

What this trial tests

trial testing MotoMeds Healthline- illness assessment and treatment recommendation for non-emergent cases by telephone in Acute Diarrhea in 391 participants. Completed in 19 January 2021.

Timeline

9 September 2019

Primary endpoint
19 January 2021

19 January 2021

Quick facts

Lead sponsor	University of Florida
Status	Completed
Study type	OBSERVATIONAL
Enrollment	391
Start date	9 September 2019
Primary completion	19 January 2021
Estimated completion	19 January 2021
Sites	1 location across Haiti

Drugs / interventions tested

• MotoMeds Healthline- illness assessment and treatment recommendation for non-emergent cases by telephone

Conditions studied

• Acute Diarrhea — all drugs for Acute Diarrhea →
• Acute Respiratory Infection — all drugs for Acute Respiratory Infection →
• Acute Febrile Illness — all drugs for Acute Febrile Illness →

Sponsor

University of Florida

Who can join

Under 10, any sex, with Acute Diarrhea or Acute Respiratory Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Children in resource-limited settings who develop illness at night are often isolated from pre-emergency care, resulting in progression to an emergency because families are forced to wait until morning to seek care. This is especially true in Haiti based on needs assessments (INACT Part 1; INACT1) surrounding access to healthcare. This study (INACT Part 2; INACT2) seeks to improve access to care by establishing a health hotline (healthline) and mobile pharmacy for families with children who become ill at nighttime. The healthline will be staffed by medical professionals and will provide phone based assessment and treatment recommendations based on standard of care practices according to Haitian and WHO guidelines. The healthline will focus on pre-emergency patients (those without danger signs as defined by WHO guidelines). Emergent patients will be advised to bypass the healthline and seek immediate care at the nearest medical facility. In the event that a non-emergent patient requires access to basic medications or fluids and is logistically accessible, the mobile pharmacy service will be offered.

The specific aims of the study are as follows: Aim I. Evaluate congruence between healthline assessment over the phone and in-person assessment of participants (patients using the healthline) 10 years of age and younger. The investigators hypothesize that in-person assessments based on WHO guidelines will be discordant with those made by the healthline because the physical aspects of the call-center assessment will be performed by an untrained parent/ guardian. The study focuses on acute diarrheal disease (ADD) and acute respiratory illness (ARI) but is not exclusive to these two chief complaints. Aim II: Identify determinants that correlate with seeking care at a medical facility over the 8-12 day follow up period after the initial call. The findings from this study will determine if a healthline model is a safe and accurate method of providing high quality access to nighttime healthcare, averting the progression of non-emergent cases to emergencies.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Implementation of a Pediatric Telemedicine and Medication Delivery Service in a Resource-limited Setting: A Pilot Study for Clinical Safety and Feasibility.
   Klarman MB, Flaherty KE, Chi X, Cajusma Y, et al · · 2023 · cited 14× · PMID 36528053 · DOI 10.1016/j.jpeds.2022.12.005
2. Development and evaluation of a clinical guideline for a paediatric telemedicine service in a low-resource setting.
   Klarman MB, Chi X, Cajusma Y, Flaherty KE, et al · · 2024 · cited 9× · PMID 38191203 · DOI 10.1136/bmjpo-2023-002164
3. Implementation of a pediatric telemedicine and medication delivery service in a resource-limited setting: A pilot study for clinical safety and feasibility
   Klarman MB, Flaherty KE, Chi X, Cajusma Y, et al · · 2022 · cited 2× · DOI 10.1101/2022.04.26.22273923